NCT07087938

Cannabichromene Safety in Rheumatoid Arthritis

Safety and Behavioral Pharmacology of Cannabichromene as an Adjunct to Rheumatoid Arthritis Treatment; Effects on Inflammatory Markers and Rheumatoid Arthritis Disease Activity

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Crystal Lederhos Smith · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

For this quantitative study, the investigators will collect data on human safety and side-effects of Cannabichromene (CBC) and whether CBC reduces blood inflammatory markers and Rheumatoid Arthritis (RA) disease activity. The participants will participate in an ABAB design with 2 doses of CBC across the A phases. They will attend 5 in-person clinic visits where they will have physical evaluations, complete self-report forms, and have blood drawn for the following tests: hs-CRP, ESR, IL-6, TNF, Complete Blood Count \[CBC\], and CMP.

Detailed description

Due to their anti-inflammatory effects, cannabinoids have been considered as a potential therapy for the treatment of rheumatic diseases in humans. However, there is not yet significant evidence for the efficacy of cannabinoid-based treatments for rheumatoid arthritis, even though it is included in the list of eligible conditions for medical cannabis in Canada and many US states. In this study, the investigators propose to examine the safety and human behavioral pharmacology of CBC: No statistical hypotheses have been developed for Aims 1 and 2 as they are descriptive in nature. Aim 3 has the statistical hypothesis embedded within it. These are reiterated below: Aim 1: Assess human safety of CBC through a count of the number of treatment-related adverse events experienced by participants. This is a descriptive aim and therefore does not have an associated hypothesis. Aim 2: Assess human safety of CBC through measurement of blood markers indicating organ function. This is a descriptive aim wherein the investigators will provide a qualitative description of changes in blood markers during treatment; it therefore does not have an associated hypothesis. Aim 3: Determine if CBC reduces blood inflammatory markers and overall rheumatoid arthritis disease activity (as measured by the DAS28), across 2 dosages (400mg and 600mg CBC daily), each administered for an 8-week period. The investigators hypothesize that CBC will yield lower levels of inflammatory markers and overall disease activity during the treatment period and that levels of inflammatory markers will return to baseline at the 2-week follow-up for both of the doses.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Cannabichromene	Participants will be assigned (using block randomization) to begin with one of the two study doses of CBC (400mg or 600mg). Participants will be blinded to dose. They will be asked to take half of their dose in the morning and half in the evening. Participants will be administered dose one for eight weeks. After this, participants will have a two-week timeframe where they will be asked not to take any study medication and to continue refraining from cannabis use, thus providing a washout period. Then, at visit three, they will receive dose two and will take it for eight weeks, concluding the study with another two-week washout period. At each clinic visit participants will complete assessments (self-report and physical examination), urine, and blood samples.

Timeline

• Start date: 2028-07-15
• Primary completion: 2030-05-31
• Completion: 2030-05-31
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study